How does a clinic get its licença sanitária in Brazil?

Every Brazilian health service needs a current licença sanitária from its state or municipal vigilância sanitária, displayed where the public can see it, under article 10 of ANVISA's RDC 63/2011. In São Paulo the city registers clinics in the CMVS through COVISA, and in Rio de Janeiro IVISA-Rio issues a Licença Sanitária de Funcionamento that is revalidated every year by 30 April.

Who issues the licence

ANVISA sets the national rules, and the licence itself comes from the sanitary body of the state, the Federal District or the municipality. RDC 63/2011 defines the licença atualizada as the document that body issues to permit an establishment to operate, applies to every health service in the country, public or private, and requires the licence to be current and displayed in a place visible to the public.¹ Under Lei 6.437/1977, building, installing or running a clinic without a licence from the competent sanitary body is an infraction, punished by a warning, interdiction, cancellation of the licence or a fine.² Fines run from R$2,000 for a minor infraction to R$1.5 million for the most serious, and double on a repeat.²

São Paulo and Rio de Janeiro

In São Paulo, ANVISA coordinates the national system, the state's Centro de Vigilância Sanitária regulates for the state, and the city's Coordenadoria de Vigilância em Saúde (COVISA) regulates and inspects inside the municipality under the Código Sanitário, Lei 13.725/2004.³ The CMVS, the Cadastro Municipal de Vigilância Sanitária, is the number the city gives to establishments whose activities its rules list, and it is mandatory to operate them.⁴ The rules in force are Portaria SMS 266/2025, published on 6 May 2025.⁵ X-ray and other ionising radiation equipment needs its own licence, and the city says it charges no fee for the registration or the inspection.⁴

In Rio de Janeiro, an establishment subject to sanitary licensing applies within 30 days of receiving its alvará or authorisation from the city's finance department, and revalidates the Licença Sanitária de Funcionamento every year by 30 April.⁶ The annual request is made online with a Gov.br account, the fee is paid on the generated guide, and the licence issued must be displayed to the public.⁶

1. Confirm the activities. List every service the clinic will offer, including imaging, so each one is licensed.
2. Name the responsável técnico. RDC 63/2011 asks for a responsável técnico and a substitute, and for the sanitary body to be told of any change.
3. Approve the architecture. Keep the Projeto Básico de Arquitetura approved by the vigilância sanitária and current.
4. Register in the CNES. Every health service must be in the Cadastro Nacional de Estabelecimentos de Saúde, with its data kept up to date.
5. Apply to the city or state. The CMVS through COVISA in São Paulo, the LSF through IVISA-Rio in Rio de Janeiro.
6. Display the licence. Fix it where the public can see it, and diary any annual revalidation.

1. City ______ Body ______
2. Activities licensed ______
3. Responsável técnico ______ Substitute ______
4. CNES number ______ CMVS or LSF number ______
5. Architecture approved on ______
6. Licence issued on ______ Revalidation due ______
7. Displayed at ______

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What the vigilância expects on file

RDC 63/2011 asks every health service to keep an up to date regimento interno describing its activities and responsibilities, to be registered in the CNES, to have a responsável técnico and a substitute, and to keep records on hand covering occupational health, training, outsourced service contracts, maintenance, waste management, adverse events and its written procedures.¹ The licence also opens the next step, because the Conselho Regional de Medicina asks for the alvará da vigilância sanitária when a clinic registers as a company.⁷

Questions

Can a clinic open before the licença sanitária is issued?

Lei 6.437/1977 makes running a clinic without a licence from the competent sanitary body an infraction, so plan to open after it is issued.

Who issues the licence, ANVISA or the city?

The state, the Federal District or the municipality issues it. ANVISA sets the national rules in RDCs such as RDC 63/2011.

How often is the Rio licence renewed?

IVISA-Rio's Licença Sanitária de Funcionamento is revalidated every year by 30 April.

Does São Paulo charge to register a clinic in the CMVS?

The city says its vigilância charges no fee for the registration or at the inspection, and treats any such demand as a false inspector.

Sources

1. 1ANVISA, AnvisaLegis, 2011Resolução RDC nº 63, de 25 de novembro de 2011, Requisitos de Boas Práticas de Funcionamento para os Serviços de SaúdeRead source
2. 2Presidência da República, Planalto, 1977Lei nº 6.437, de 20 de agosto de 1977, infrações à legislação sanitária federal e sançõesRead source
3. 3Prefeitura de São Paulo, Secretaria Municipal da Saúde, 2024Vigilância Sanitária, COVISA e o Código Sanitário do Município (Lei 13.725/2004)Read source
4. 4Prefeitura de São Paulo, Secretaria Municipal da Saúde, 2024Vigilância Sanitária, Perguntas Frequentes (CMVS, autoridade sanitária, legislação)Read source
5. 5Prefeitura de São Paulo, Secretaria Municipal da Saúde, 2026Licença Sanitária, CMVS, Portaria SMS nº 266/2025Read source
6. 6Prefeitura da Cidade do Rio de Janeiro, IVISA-Rio, 2026Licença Sanitária de FuncionamentoRead source
7. 7Conselho Federal de Medicina, 2011Resolução CFM nº 1.980/2011, cadastro, registro e responsabilidade técnica das pessoas jurídicasRead source

Written by the wai team from ANVISA and the vigilância sanitária, the Conselho Federal de Medicina and the CRMs, and the Organização Nacional de Acreditação guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither ANVISA, the CFM nor ONA endorses wai or any software.